2015 ISAKOS Biennial Congress ePoster #1007

A Prospective, Blinded Multi-Center Clinical Trial to Compare Efficiency, Accuracy, and Safety of the Visionscope Imaging System Compared to MRI and Diagnostic Arthroscopy

John Xerogeanes, MD, Brookhaven, GA UNITED STATES
Kaitlin M. Carroll, BS, New York, NY UNITED STATES
Bert R. Mandelbaum, MD, DHL(Hon), Santa Monica, CA UNITED STATES
William Robertson, MD, Dallase UNITED STATES
Ralph Gambardella, MD, Los Angeles, CA UNITED STATES
Marc R. Safran, MD, Prof., Redwood City, CA UNITED STATES
Bryan M Huber, MD

Emory University, UT Southwestern, Stanford, Copley Orthopaedics, Kerlan Jobe, SMOG, Various Cities, USA

FDA Status Not Applicable

Summary: VSI provides a way for physicians to perform in-office diagnostic exams for intra-articular pathology without the need for more costly and less accurate MRI examination, or more invasive and expensive surgical arthroscopy

ePoster Not Provided
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Abstract:

Background

Until now, arthroscopic surgery has been the gold standard for the diagnosis of intra-articular pathology. When a patient presents with ongoing pain and/or disability despite non-operative care, MRI is commonly used as an initial diagnostic modality. Currently, there is not a minimally invasive in-office option that can provide detailed anatomic information about the intra-articular pathology of a joint in real time.

Hypothesis/Purpose: The purpose of this study was to compare the efficacy, accuracy and safety of VisionScope Imaging (VSI) compared to MRI and diagnostic arthroscopic surgery.

Study Design: Prospective Case Series

Methods

A prospective, multi-center, blinded clinical trial was performed of 110 patients age 18 -75 years who presented with knee pain. Each patient underwent a MRI, VSI exam and surgical diagnostic arthroscopy. The attending physician completed clinical trial forms (CRF) comparing the VSI exam findings to the diagnostic arthroscopy findings on each patient. Two blinded experts unaffiliated with the clinical patient care reviewed the VSI and MRI images. The arthroscopy served as the “control” comparison between the VSI and MRI findings.

Results

In this study, the accuracy, sensitivity and specificity of VSI was equivalent to surgical diagnostic arthroscopy and more accurate than MRI. When comparing VSI to arthroscopy, all of the Kappa statistics were above 0.766, and went as high as 0.902. For MRI compared to arthroscopy, Kappa values ranged from a high of 0.535 (considered “moderate” agreement), to a low of 0.130 (considered “slight” agreement). The comparison of VSI to MRI showed very similar results as arthroscopy to MRI, with a highest Kappa of 0.546 and a lowest Kappa of 0.112.

Conclusions

VSI is statistically equivalent to diagnostic surgical arthroscopy with regard to the diagnosis of intra-articular knee joint pathology. When compared to MRI, a VSI exam can provide a more detailed and accurate diagnostic assessment of intra-articular knee pathology. Based on our study results, VSI provides an accurate, real-time, minimally invasive diagnostic modality that can be performed to evaluate intra-articular pathology in the office setting without the need for surgical arthroscopy or high-cost imaging such as MRI, and with a high degree of patient satisfaction.